FDA launches effort to review infant formulas
The Food and Drug Administration (FDA) announced a new initiative Tuesday titled “Operation Stork Speed” aimed at reviewing ...
FDA launches Operation Stork Speed to enhance oversight for infant formula
This initiative builds on the agency’s January announcement to “enhance” oversight of infant-formula production as part of a ...
FDA to increase testing for heavy metals in infant formula, RFK Jr. says
The U.S. Food and Drug Administration will step up its testing for heavy metals in infant formula and review nutrients ...
BizPac Review12h
Stephen Moore: The FDA can save lives by keeping copycat drugs off the market
The future of American drug innovation is threatened by US regulations that permit knockoff versions of new drugs to be sold to US consumers.
Stockhead on MSN18h
Biocurious: FDA approval remains the Holy Grail for ASX life science stocks
Despite the Trump administration's shake-up of the agency, the US FDA is the first port of call for most ASX biotechs.
Zacks Investment Research on MSN4h
JNJ's Nipocalimab Gets FDA's Fast Track Tag for Sjogren's Disease
Johnson & Johnson JNJ announced that the FDA has granted a Fast Track designation (“FTD’) to its investigational drug, ...
ConsumerAffairs7h
Infant formula is under scrutiny at the FDA
Health and Human Services Secretary Robert F. Kennedy, Jr., has turned his attention to infant formula, with the goal of ...
Managed Healthcare Executive2d
FDA Grants Priority Review to Kerendia in Heart Failure
Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with ...
Zacks Investment Research on MSN4h
FDA Accepts RDY & ALVO's Prolia & Xgeva Biosimilar BLA for Review
Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...
JD Supra3h
FDA Funding Changes Could Impact Biotech M&A
With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment ...
XORTX Announces Update for Discussion with the FDA
● Type B Meeting Discussion to Accelerate XRx-026 for Gout to NDA ● ...
Bayer Gets Speedy FDA Review of Kerendia in Heart Failure
Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure.